Spots Global Cancer Trial Database for A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
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Trial Identification
Brief Title: A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
Official Title: A Phase 1b/2 Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation
Study ID: NCT03684811
Conditions
Study Description
Brief Summary: This Phase 1/2 study will evaluate the safety, efficacy, PK, and PD of FT-2102 as a single agent and in combination with other anti-cancer drugs in patients with advanced solid tumors and gliomas. The study is divided into two parts: single agent FT-2102 followed by combination therapy. Part 1: A single agent, open-label study in up to five cohorts (glioma, hepatobiliary tumors, chondrosarcoma, intrahepatic cholangiocarcinoma, and other IDH1 mutant solid tumors) that will include a Phase 1 dose confirmation followed by a Phase 2 investigation of clinical activity in up to 4 cohorts. During the dose confirmation, additional doses or altered dose schedules may be explored. Part 2: An open-label study of FT-2102 in combination with other anti-cancer agents. Patients will be enrolled across 4 different disease cohorts, examining the effect of FT-2102 + azacitidine (glioma and chondrosarcoma), FT-2102 + nivolumab (hepatobiliary tumors), and FT-2102 + gemcitabine/cisplatin (intrahepatic cholangiocarcinoma). There will be a safety lead-in followed by a Phase 2 evaluation in up to four cohorts of patients.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson, Gilbert, Arizona, United States
University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States
University of Miami, Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Northwestern University, Lurie Comprehensive Cancer Center, Chicago, Illinois, United States
University of Iowa, Holden Comprehensive Cancer Institute, Iowa City, Iowa, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Henry Ford Hospital, Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
Columbia University Medical Center, New York, New York, United States
Baylor Scott and White Medical Center, Temple, Texas, United States
University of Utah, Huntsman Cancer Hospital, Salt Lake City, Utah, United States
Medical College of Wisconsin, Froedtert Hospital, Milwaukee, Wisconsin, United States
Austin Hospital, Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, , Australia
Centre de Lutte Contre Cancer (CLCC) - Institute Bergonie, Bordeaux, , France
Centre de Lutte Cancre (CLCC) - Lyon, Lyon, , France
Hospital de la Timone, Marseille, , France
Institut Gustave Roussy Cancer Campus, Villejuif, , France
Seoul National University Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Vall D'Hebron University Hospital, Barcelona, , Spain
Cancer Research Beatson Institute, Glasgow, , United Kingdom
The Royal Marsden Hospital, London, , United Kingdom
Contact Details
Name: Emma Barrett
Affiliation: Forma Therapeutics
Role: STUDY_DIRECTOR
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